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Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients

Sponsor
Case Western Reserve University (Other)
Overall Status
Terminated
CT.gov ID
NCT00004415
Collaborator
(none)
5
Enrollment
112.1
Duration (Months)

Study Details

Study Description

Brief Summary

OBJECTIVES: I. Determine whether combined intercostal muscle and diaphragm pacing can maintain full-time ventilatory support in patients with ventilatory dependent quadriplegia who are not candidates for phrenic nerve pacing alone.

  1. Evaluate the efficacy of the Medlink device to produce synchronous intercostal and diagram activation in these patients.
Condition or Disease Intervention/Treatment Phase
  • Device: Medlink spinal cord electrode
 N/A

Detailed Description

PROTOCOL OUTLINE: Patients have a Medlink spinal cord electrode surgically implanted and attached to a radiofrequency receiver implanted subcutaneously over the anterior chest wall.

If substantial inspired volumes can be generated by intercostal pacing, a phrenic nerve cuff electrode and radiofrequency receiver are implanted, and patients undergo combined intercostal muscle and diaphragm pacing.

Completion date provided represents the completion date of the grant per OOPD records

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Study Start Date :
May 1, 1991
Study Completion Date :
Sep 1, 2000

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    PROTOCOL ENTRY CRITERIA:

    --Disease Characteristics--

    Ventilator dependent quadriplegics who are not candidates for phrenic nerve pacing alone

    Must have bilateral partial or unilateral phrenic nerve function

    Must have been on ventilator support for at least 6 months and unweanable

    --Patient Characteristics--

    Cardiovascular: No active cardiovascular disease

    Pulmonary: No active lung disease

    Other: No active brain disease Stable condition

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Case Western Reserve University

    Investigators

    • Study Chair: Anthony F. DiMarco, Case Western Reserve University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004415
    Other Study ID Numbers:
    • 199/13307
    • CWRU-09169-M-91
    • CWRU-FDR000403
    First Posted:
    Oct 19, 1999
    Last Update Posted:
    Apr 7, 2015
    Last Verified:
    Sep 1, 2002
    Keywords provided by , ,
    environmental/toxic disorders
    neurologic and psychiatric disorders
    rare disease
    spinal cord injury
    Additional relevant MeSH terms:
    Quadriplegia

    Study Results

    No Results Posted as of Apr 7, 2015